Methylprednisolone With or Without Daclizumab in Treating Patients With Acute Graft-Versus-Host Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2003 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00053976
First received: February 5, 2003
Last updated: February 6, 2009
Last verified: December 2003

February 5, 2003
February 6, 2009
October 2002
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Complete list of historical versions of study NCT00053976 on ClinicalTrials.gov Archive Site
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Methylprednisolone With or Without Daclizumab in Treating Patients With Acute Graft-Versus-Host Disease
Treatment of Acute Graft vs. Host Disease With Steroids Plus Daclizumab (Zenapax) or Placebo

RATIONALE: Daclizumab combined with methylprednisolone may be an effective treatment for acute graft-versus-host disease caused by bone marrow transplantation. It is not yet known if methylprednisolone is more effective with or without daclizumab in treating acute graft-versus-host disease.

PURPOSE: Randomized phase III trial to compare the effectiveness of methylprednisolone with or without daclizumab in treating patients who have acute graft-versus-host disease following donor bone marrow transplantation.

OBJECTIVES:

  • Compare response to treatment in patients with acute graft-versus-host disease (GVHD) treated with methylprednisolone with or without daclizumab.
  • Compare differences in total methylprednisolone dose and complications in patients treated with these regimens.
  • Compare mortality, days of antibiotics and antifungal therapy, and required hospital days within the first 100 days for patients treated with these regimens.
  • Compare overall survival and incidence of chronic GVHD at 1 year in patients treated with these regimens.

OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to prior graft-versus-host disease (GVHD) prophylaxis (immunosuppressive therapy vs T-cell depletion), GVHD organ manifestation (skin only vs other), donor type (6/6 matched sibling vs other), and participating center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive methylprednisolone or equivalent corticosteroid IV or orally and daclizumab IV over 15 minutes on days 0, 3, 7, 14, and then weekly as indicated until day 100.
  • Arm II: Patients receive methylprednisolone or equivalent corticosteroid as in arm I and placebo.

Patients are followed at 1 year and then annually thereafter.

PROJECTED ACCRUAL: A total of 166-190 patients will be accrued for this study within 2 years.

Interventional
Phase 3
Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Supportive Care
Graft Versus Host Disease
  • Biological: daclizumab
  • Drug: methylprednisolone
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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DISEASE CHARACTERISTICS:

  • Acute graft-versus-host disease (GVHD) requiring systemic therapy

    • Grade 2 (skin GVHD)
    • Grade 2-4 (overall GVHD)
  • Received allogeneic bone marrow transplantation
  • No acute GVHD diagnosed solely by upper gastrointestinal involvement
  • No GVHD from donor lymphocyte infusion

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No mental or emotional conditions that would preclude study therapy
  • No known hypersensitivity to daclizumab

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • No prior daclizumab

Chemotherapy

  • Not specified

Endocrine therapy

  • More than 7 days since prior prophylactic or therapeutic steroids at greater than 1 mg/kg/day
  • Steroids for amphotericin premedication allowed provided dose is less than 1 mg/kg/day

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • More than 30 days since prior investigational therapies
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00053976
CDR0000269672, DFCI-99279, RPCI-DS-0218, ROCHE-RPCI-DS-0218
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Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Study Chair: Stephanie J. Lee, MD Dana-Farber Cancer Institute
National Cancer Institute (NCI)
December 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP